Updated Recommendation for Universal Hepatitis B Vaccination in Adults Aged 19–59 Years — United States, 2024

Abstract

Hepatitis B (HepB) vaccines have demonstrated safety, immunogenicity, and efficacy during the past 4 decades (1,2). The Advisory Committee on Immunization Practices recommends universal HepB vaccination for adults aged 19-59 years, including pregnant persons, and adults aged ≥60 years with risk factors for hepatitis B. Adults aged ≥60 years without known risk factors for hepatitis B may also receive HepB vaccines (2). On September 11, 2024, the Food and Drug Administration approved a request to update the labeling for Heplisav-B vaccine with new indications for use among pregnant persons (3,4). A postlicensure observational retrospective cohort study (DV2-HBV-28)* included 75 pregnancies with known outcomes , including 10 among persons who received Heplisav-B twice during the period from 28 days before conception through the end of pregnancy. Among 75 pregnant persons with exposure to Heplisav-B before or during pregnancy, 44 received Heplisav-B during the 28 days before conception, 24 during the first trimester, six during the second trimester, and one during the third trimester. No major birth defects were identified, and the risk for miscarriage was below the estimated background risk. These available data, primarily for persons who received 1 dose of Heplisav-B during the 28 days before conception, or during pregnancy, do not suggest an increased risk for both major birth defects and miscarriage. Approval